Many types of implantable medical devices require a source of electrical energy. For example, pacemakers, defibrillators, drug infusion pumps, cochlear implants, and brain activity monitoring/stimulation systems all require a power source. Many of these implantable medical devices provide therapy and/or diagnostic functions, and have significant electrical power requirements.
Electrical current used to supply the electrical power required by an implanted medical device can be conveyed through an electrical lead that is connected to the device and extends outside the patient's body for connection to an external power source. However, a transcutaneous lead that passes through the skin increases the risk of infection when left in place for an extended period. Implanted medical devices may also be powered by a non-rechargeable battery. However, replacement of such a battery subjects the patient to further surgery, and thus, may not be desirable, particularly if replacement is frequently necessary.
As an alternative to a non-rechargeable battery, an implanted rechargeable battery can be recharged by transcutaneously coupling power from an external source to an implanted receiver that is connected to the rechargeable battery. One of the more efficient recharging techniques employs an external transmission coil and an internal receiver coil, which are inductively coupled so that power can be conveyed from the transmission coil to the receiver coil. In this transcutaneous energy transmission (TET) approach, the external primary transmission coil is energized with alternating current (AC), producing a time varying magnetic field that passes through the patient's skin and induces a corresponding AC in the internal secondary receiving coil. The voltage induced in the receiving coil may then be rectified to provide direct current (DC) that is used to power the implanted medical device and/or charge a battery or other charge storage device (e.g., an ultra capacitor), which continues to energize the implanted medical device after the inductive supply of electrical power is terminated. This transcutaneous energy transmission work was originally pioneered by J. C. Schuder in 1961 (J. C. Schuder, H. E. Stephenson, and J. F. Townsend, “High level electromagnetic energy transfer through a closed chest wall,” IRE International Convention Record 9, part 9, pp. 119-126, 1961).
One challenge in designing TET systems is that eddy currents are induced in the metallic components (such as the housing or printed circuit boards) of the implanted medical device. Such eddy currents can produce a generally undesirable temperature increase or heating of the implantable device. The amount of heat generated is generally a function of the amplitude and frequency of the magnetic flux used in the TET system.
Additional thermal challenges presented in TET systems are caused by the heat produced within the external transmission coil and its associated external enclosure. One problem is that temperature increases in the external transmission coil decreases the efficiency of the TET system. For example, heating of the primary coil increases the resistance of the windings, which serves to reduce the amount of power transferred to the implantable unit, thereby increasing the time required for recharging, resulting in further heating of the external transmission coil enclosure and the heating of the implanted medical device. A second problem is that as the external transmission coil heats up, such heat can be transferred to the external housing surrounding the coil. That housing is located proximal to the patient's skin nearest the implanted medical device, and such a temperature increase can increase the skin temperature.
Implanted medical devices are generally surrounded by tissue, which to a certain extent will conduct heat away from the device. However, implanted device temperatures exceeding safe thresholds may injure or permanently damage surrounding tissue. The ability of human tissue to withstand hyperthermic conditions is governed by a complex relationship of factors including tissue type, temperature, and exposure time. It would be desirable to provide a method and apparatus that reduces the risk of damaging adjacent tissue during the recharging of implanted medical devices when using TET. Furthermore, the amount of transmitted power is primarily limited by the heating of (i) the tissue surrounding the implanted device; (ii) the skin surface adjacent to the external charging device; and (iii) the temperature of the external charging device. Such aforementioned heating limits the amount of power that may be transferred by the TET system, which increases the time required for recharging. Since the patient is typically inconvenienced during the recharging period, it would be desirable to maximize the power rate of transfer while minimizing associated heating. Prospective techniques for accomplishing that may employ one or more of the following strategies: (1) minimizing the heat caused by induced eddy currents; (2) transferring heat away from the tissue surrounding the implantable medical device; (3) reducing the operating temperature of the external components of the TET system; and, (4) isolating any temperature elevation of the external components of the TET system from the tissue proximate the implanted medical device.